You've probably heard the oft-repeated charge of "alternative" medicine advocates. If you get into a debate or conversation with one, you can almost count on seeing or hearing it before too long. Indeed, we heard a variant of this very claim yesterday coming from Ã¼ber-woomeister supreme Deepak Chopra. I'm referring, of course, to the rant against "conventional" medicine that medication errors claim 100,000 lives a year. Of course, as Mark pointed out, "conventional" therapies actually work, and because they work there's risk to them. Moreover, its hospitals actually care for seriously ill patients. However, even so, medical errors are more prevalent than they should be, and this is where the difference between "conventional" and alternative medicine is most apparent. No, not because conventional medicine produces errors. What I'm referring to is how, unlike "alternative" medicine, conventional medicine is engaged in a concerted effort to minimize medical errors, be they systemic or by individual physicians.
As hard as it may be for some to believe, in many cases surgeons are spearheading such efforts, doing studies that seek to identify causes of bad outcomes and surgical errors. Not long ago, I discussed one such study, which looked at morbidity and mortality rates by the month in teaching hospitals and seemed to indicate that morbidity and mortality increased in July and August, paralleling the arrival of new interns, residents, and fellows every year. The studies had some flaws, but the effort was admirable. Now, hot off the presses in this month's Annals of Surgery is study that seeks to characterize patterns in surgical errors. It's coauthored by Dr. Atul A Gawande, the Harvard surgeon who's made a name for himself with his books Complications: A Surgeon's Notes on an Imperfect Science and Better: A Surgeon's Notes on Performance, both of which deal with complications of surgery and how to improve medical care.
The study, Patterns of Technical Error Among Surgical Malpractice Claims: An Analysis of Strategies to Prevent Injury to Surgical Patients, took a rather clever strategy. As much as we physicians hate it, malpractice suits represent a source of data that is seldom used but can often identify glaring medical errors that can't be ascribed, even obliquely, to differences in surgical opinion. We're talking about wrong-side surgery errors and the like. Of course, while I find the information in this data as interesting and potentially useful as Dr. Gawande did, I would be remiss if I didn't point out that the threat of malpractice suits can also distort medical care, leading doctors to practice "defensive" medicine, actually increasing the risk of mistakes by subjecting the patient to more tests and procedures. Be that as it may, actual malpractice suit data do provide a unique insight into surgical errors.
Such an insight is needed because, as the article points out right in the first paragraph, between one-half and two-thirds of hospital adverse events are attributable to surgery and surgical care. Also, the sorts of errors that occur in surgical care tend to be different than those that occur on medical services, making many of the studies of medication errors in hospitals not easily generalizable to surgical care. The big difference is that most surgical errors occur in the operating room and most are "technical" in nature. Technical errors are errors in which some aspect of the surgery is not done properly, and can include errors of manual skill and errors of "surgical judgment" (i.e., decision-making in the operating room) or knowledge. An example of a purely technical error includes accidentally cutting something that shouldn't be cut, whether due to carelessness or failure to identify the anatomy properly, or a tie on a blood vessel that's improperly tied, leading it to fall off later. These errors, if recognized promptly at the time of surgery, often cause little or no morbidity because the surgeon can fix the problem right away, such as when surgeon makes an accidental knick in the bowel, sees the hole, and sews it up right away. If unrecognized, however, such technical complications can lead to devastating complications, the hole in the bowel being a classic example, which may not be recognized if small. The patient will slowly leak stool into the abdomen and become really septic within a few days of surgery.
Another class of surgical error is the error in knowledge or judgment. Surgery is unique among medical specialties in that, while doing operations surgeons are constantly making decisions in real time and acting on them. There's not much time to contemplate, because you can't leave the patient under anaesthesia while you walk off to the library to look up literature on what you should do. This aspect of surgery is often what is tested on board examinations, where the candidate will be asked what he or she would do, for instance, if a certain unexpected finding were to be encountered at the time of surgery. One classic example of a "judgment" question is what to do if you find an ovarian mass in a woman undergoing a splenectomy for a hematological disease. Another is what to do if an abdominal aortic aneurysm is found at the time of surgery for a malignant polyp. (These days, if a patient has a decent-sized colon cancer, he would be likely to have had a preoperative CT scan, which would identify the aneurysm making this question a little less relevant than it was, say 20 years ago.) Errors in knowledge tend to involve doing the wrong procedure for a condition, a classic example being performing a simple cholecystectomy for an invasive gallbladder cancer.
These sorts of errors can occur at any phase of surgical care, and numerous studies have been done to try to identify causes. Such errors and adverse outcomes have been attributed to low hospital volume, breakdowns in communication, systems shortcomings, fatigue, lack of experience in trainees, and many other causes. These studies have led to many proposals of how to minimize such errors, many of which are controversial, such as referral of certain kinds of cases only to high volume centers.
In order to characterize surgical errors that led to serious injury to patients, this study examined a database of closed malpractice claims. 444 such claims were examined in which 258 were identified in which an error resulted in an injury. Examining the claims, reviewers identified 135 (52%) in which it was judged that a technical error was a major contributing factor to patient injury. Error was defined according to the Institute of Medicine definition: "the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (error in planning)." Technical errors were those where reviewers believed that an error of operative technique directly contributed to the adverse outcome, either because of manual error (error of execution causing injury to viscera or vasculature, for example) or judgment or knowledge error (wrong timing, wrong selection of procedure, failure to diagnose complications, wrong site surgery).
There were 140 technical errors identified. Attending surgeons were responsible for 69% while 27% involved both the attending and trainee. Reassuringly, only 4% were due to actions by surgical residents or fellows alone. Less reassuringly, most of the technical errors caused serious injuries, with 49% resulting in permanent disability and 16% resulting in death. Not too surprisingly, given that these were severe errors, the kinds that lead to malpractice suits, 31% involved gastrointestinal surgery, 15% spine surgery, 12% gynecologic surgery, and 9% non-spine orthopedic surgery. In terms of error type, 91% of technical errors involved manual error and 35% involved judgment or knowledge errors. A summary of the types of manual versus judgment/ knowledge errors is summarized in this table:
Perhaps the most interesting findings were the contributing factors to technical errors. Not surprisingly, 69% of technical errors involved complicating factors, with 61% having patient-related factors (difficult or unusual anatomy 25%; reoperation 20%; urgent or emergency operations 17%). There were also a number (16%) of equipment use misadventures. Not surprisingly, experienced surgeons were less likely to have equipment use misadventures than inexperienced surgeons and more likely to make errors related to reoperative surgery. The reason this is not surprising is that the anatomy is often hard to ascertain in reoperative surgery due to scarring and adhesions, and more experienced surgeons are more likely to attract referrals of more difficult patients. What one might find surprising on the surface is this comment in the discussion:
Almost three-fourths of technical errors in this study involved fully trained and experienced surgeons operating within their area of expertise and 84% occurred in routine operations, for which advanced expertise beyond a standard training program is not required or expected.
What this tells us is that it is during the common operations when errors happen most frequently. As an accompanying editorial puts it, "It is not the neophyte doing the 10-hour Whipple that leads to most malpractice claims; it is the experienced general surgeon doing a gastrectomy on a patient with three previous upper abdominal operations and a replaced left hepatic artery." This should not be that surprising, given that highly complex operations tend to be performed in academic medical centers by highly specialized surgeons and surgical teams. What this study also suggests is that the best strategy to have a rapid impact to reduce surgical error may be to develop strategies to improve decision-making, operative planning, and team performance for common, not necessarily the highly complex, operations. Moreover, it suggests that volume- or experience-based limitations on privileging for high-complexity operations would only have an impact on a relatively small minority of surgical errors. In other words, a bigger bang for the buck in this respect would likely result from focusing on interventions to improve performance and decision-making in routine operations in emergencies and on high risk patients.
Another interesting aspect of this study was raised in the editorial, namely the question of how often experience itself invites disaster:
How often did experience itself invite disaster? I am thinking of a case of my own recently where I embarked on a difficult liver resection in an 82-year-old man who had undergone 8 cycles of chemotherapy. The lesion was in an awkward place and I knew of the increased risk. Yet, my experience made me confident that I could "get away with" a procedure that I would flunk a young surgeon for if she proposed it during a board examination. This reminds me of the comment made by the first officer of an airliner that ran off the runway in Burbank, California, after an unstabilized, too fast, nighttime approach. "I'd seen it work out before," he said.
This is a telling observation. Pretty much every surgeon knows of a "cowboy" who loves taking on the most difficult, highest risk cases, sometimes even to the point of going too far and operating on patients who probably should not be operated on. They may be so good that they do "get away with it" most of the time, but it's still riskier than it should be.
I think the takehome message from this study is, as for many things in surgery, that simple interventions in common problems are likely to yield the most benefit. Big cases like Whipples and liver resections are often examined at a frequency that far outstrips their actual frequency relative to common operations like hernia repairs and cholecystectomies. After all, the median number of Whipple operations done by a typical private practice general surgeon per year is zero, while the same surgeons may do a couple hundred or more laparoscopic cholecystectomies during that same time It would almost certainly pay off more dramatically to take care of fixing factors leading to errors in the common "bread and butter" operations first.
Very interesting. I found the analogy to a pilot-error anecdote particularly interesting, because as I read this article, I was strongly reminded of an article earlier this year in Air & Space Magazine concerning the vexing problem of runway incursions and various ground accidents (or near-accidents) involving taxiing aircraft. It also reminded me of the stubbornly persistent problem of pilot error. Another vexing problem is controlled flight into terrain -- what seems like a very stupid mistake to make, similar to wrong-site surgery, but which is sometimes made even by very experienced pilots, including elite test pilots (normally among the most safety-minded people on Earth, contrary to Hollywood's fighter-jock stereotype).
The problem is human error, and there should be procedural solutions to mitigate it. I understand that some surgeries are now taking a page from aviation and using checklists for even the stupid things. Checklists may seem intrusive, but they've saved many pilots who forgot to unlock the yoke, for instance, or who forgot that the "remove before flight" cover was still on the intake for the airspeed indicator. If you ever watch NASA TV, you'll see that this strategy is taken to the limit, with almost every action on orbit done according to a written procedure, even though the astronauts have trained on the procedure so many times that they can probably do it blindfolded. In surgery, checklists can help prevent some of the more common mistakes. Unfortunately, they can only prevent mistakes which the checklist author predicted might occur, and there are many things that it just doesn't make sense to put on a checklist, because surgery (like flying) has elements which cannot be predicted.
Even so, there have to be ways to improve. The A&S article talked about many systems intended to address some of the problems observed with runway incursions and collisions on taxiways. Lack of situational awareness, miscommunication, and excessive workload seem to show up a lot. But you can't start solving these problems until you have an idea of what the root causes are, so I'm glad to see this sort of study being done in surgery.
A couple of observations:
First, the comparison to airline pilots was apt. Both surgeons and pilots are highly trained professionals that in most cases are overtrained. (Heck, give me two hours of training and I could fly a 747 in level flight under a clear sky.) The training is really for the hard cases, the ones that come infrequently (the night-time carrier landing in the rain, the emergency ceasarian in the 500 pounder, etc.)
Second, human beings are really terrible when it comes to estimating probabilities in edge cases. Like Orac said, how many times do professionals say "it worked before"? Having done something 2 or three times safely gives everybody a false sense of security, one that can best be fought by the discussion of when things went wrong with others.
Third, question for Orac: In all the case conferences and grand rounds that you've attended, how many dealt with successes and how many with failures? I suspect mostly with the successes -- "here's how I saw something really strange and saved the patient" type stuff, not "here's what went wrong and what you other surgeons need to know to save your ass". People don't like discussing their failures, and fear of malpractice doesn't help.
Fourth, malpractice awards have only a tenuous connection to real mistakes, with awards where there is no malpractice as well as malpractice where there is no award. That makes me leary of the results of this study, leary enough to want to keep only the qualitative answers and discard the quantitative. Yes, I would agree that most mistakes are made in common surgeries, but I would hesitate to put percentages on it judging from this study.
P.S.: Sorry for the logorrhea -- my dad had a subdural hematoma yesterday, and I'm stuck 800 miles away with no idea of his prognosis. That kind of distraction doesn't help with the need to be concise.
While Grand Rounds may not always deal with error, Morbidity and Mortality Rounds do. Depending on the intstitution, these can be very, er, effective. They could be even more effective if data were compiled. Medical error is something that requires lots of sunshine, but our system discourages that.
I enjoyed the discussion regarding the differences between surgical and medical errors.
Thanks for the good read.
Second, human beings are really terrible when it comes to estimating probabilities in edge cases. Like Orac said, how many times do professionals say "it worked before"?
If you want a really vivid example of this, look for the book "Comm Check". It's about the loss of the Space Shuttle Columbia. I had the pleasure of attending a lecture by one of the Columbia Accident Investigation Board members, and he talked about this point too. The root cause of Columbia's loss was something that had occurred to varying degrees on every single flight and which had never been adequately studied or characterized -- yet which flight controllers confidently tolerated because there had yet to be an accident resulting from foam shedding.
You're quite right: it can definitely provoke a fatally false sense of security. Just because it went right last time doesn't mean it'll go right next time..
Some things are just experience-based. An experienced pilot, barring physical infirmity, can shoot an instrument landing more easily, because he's done it hundreds, if not thousands of times more than a neophyte. I've no experience in the field, but I would imagine that an experienced surgeon can do basic surgeries easier than a newly-minted cutter. Also, technology has 'helped' piloting considerably since the days of the Wright brothers. Modern day navaids and autopilot gear pretty much mean the pilot is only there to make sure that the box doesn't mess up. So, I wonder: has surgical technology improved so as to lessen the chance of accidents ?
(note: the parallels are not exact... but it's an interesting comparison so I'm running with it).
I have one small question. What in the world is a Whipple?
It's an operation of Titanic proportions ?
Then I should avoid having it done by a surgeon named Smith?
I know someone who sits on the board of a hospital, and it's interesting to hear what goes on. One interesting thing is that unless a person dies or a lawsuit is filed, a formal review isn't done.
The other interesting thing is that when a person dies, the incident investigated, and recommendations made, they are not documented. This means that new staff never benefits from recommendations or guidelines.
It's almost as if the doctors don't want to have guidelines written down that they should follow. I'm amazed at how little gets documented. It's fascinating that such an advanced group seem to want to work very independently.
Of course there is little to no communication at all between hospitals, another institutional problem.
Hope the folks at Rhode Island Hospital are taking all this to heart:
"PROVIDENCE, R.I.--Rhode Island Hospital was fined $50,000 and reprimanded by the state Department of Health Monday after its third instance this year of a doctor performing brain surgery in the wrong side of a patient's head.
more stories like this"We are extremely concerned about this continuing pattern," Director of Health David R. Gifford said in a written statement. "While the hospital has made improvements in the operating room, they have not extended these changes to the rest of the hospital."
The most recent case happened Friday when, according to the health department, the chief resident started brain surgery on the wrong side of an 82-year-old patient's head. The patient was OK, the health department and hospital said."
Would Orac or surgeons he knows be offended if a patient scrawled "Operate This Side" on their body before a procedure? :)
Dangerous Bacon said "Would Orac or surgeons he knows be offended if a patient scrawled "Operate This Side" on their body before a procedure? :)"
Several years ago a friend of mine had knee surgery and someone wrote "Cut" and "No Cut" on his legs prior to the operation to prevent such a mistake. A simple cheap and effective precaution.
Freddy the Pig,
I've heard the same story about surgeons here as well. Very simple, very effective.
There's a difference in degree between bad outcomes and malpractice. Malpractice is more closely associated with technical error; bad outcomes are contingent on a variety of factors (other co-morbidities, recurrent disease, surgical error, etc.) Malpractice suits aren't always brought against surgeons who use bad judgment or make egregious technical errors. But bad outcomes in the absence of real malpractice are major sources of malpractice suits when the surgeon is distant and unavailable afterwards.
Perhaps in this study you have academic general surgeons delegating the responsibility of talking to family members to residents and fellows. Post operatively, the attending is rarely seen as the patient lingers in the ICU with a bile leak or whatever. After all, it was just a gallbladder or a hernia.